Determining the effectiveness of online educational lifestyle intervention in the elderly with type 2 diabetes in Qazvin
Design
In order to select the samples and assign the samples to the experimental and control groups in the current study, first the research license code will be issued from the active health centers (13 health centers), 2 health centers will be selected randomly. Then, a list of all the elderly covered by the centers who actively refer to receive services and those who have a family file in the apple system will be prepared. They will then be invited to participate in the research by calling them and introducing the research and its objectives. Then, randomly in each center, if the participants are ready, one will be assigned to the control group and the other to the intervention group. After announcing the readiness of the elderly, based on a timetable, they are invited to either attend the health centers in person or, if they wish, to complete the online questionnaire online in the first phase.
Settings and conduct
Research population In the present study, all the elderly will be covered by urban health centers in Qazvin.
Participants/Inclusion and exclusion criteria
1. Voluntary and informed participation
2. Age over 65 years
3. Literacy
4. Ownership and ability to use an Android mobile phone or iOS system (the elderly person or a family member who is in regular contact with him).
5. No smoking and alcohol
6. No cancer
Intervention groups
Research population In the present study, all the elderly will be covered by urban health centers in Qazvin. We give a questionnaire to the elderly before training and we give a questionnaire after training to assess.
Main outcome variables
Perceived risk
Efficacy
Awareness
Waiting for the outcome
Action planning
Be able to plan
social support
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210509051229N1
Registration date:2022-08-30, 1401/06/08
Registration timing:retrospective
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Fateme Zanjanchi Nikoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3369 7495
Email address
f.zanjanchinikoo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of online educational lifestyle intervention in the elderly with type 2 diabetes in Qazvin
Public title
The effectiveness of online educational lifestyle intervention in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy of reading and writing
Ownership and ability to use Android mobile or IOS system
People with diabetes
Voluntary and conscious participation of people
Exclusion criteria:
Suffering from physical diseases or mental disorders that prevent proper and regular participation in any way be in research
Lack of access to the Android system and software related to What's App
Unwillingness to cooperate in further research
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a multi-stage randomization method was used. So that 130 elderly people with diabetes are needed to conduct the research and there should be 65 people in each control and experimental group. At first, 4 centers were randomly selected from 13 existing health centers in Qazvin city. Then, among these 4 centers, the number of elderly people with diabetes was removed, and among all the elderly people, by random method and using the number of 130 cards, 65 control groups and 65 experimental groups were selected. and then that card was discarded. Finally, after dividing the people into two groups, the questionnaires were completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, a questionnaire is given to individuals before training and a questionnaire is filled out once after training. This study is performed in two groups of control and intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin university of medical sciences
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2021-04-19, 1400/01/30
Ethics committee reference number
IR.QUMS.REC.1400.029
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Healthy lifestyle in diabetics
Timepoint
Before training-After training
Method of measurement
In this study, the questionnaire is the measurement scale. The questionnaire questions include the following: 1- Demographic information 2- Lifestyle questionnaire: This 19-item questionnaire was designed by Lipke and Zigelman in 2006. All questions in the questionnaire are scored on a Likert scale from one to four (completely false = 1 to completely true = 4). 3-Physical Activity Questionnaire: International Physical Activity Questionnaire, as an international physical activity measurement tool in Geneva by WHO. and CDC (1998) was suggested for the age group of 69-15 years. There are two forms of IPAQ 4- Health Action Questionnaire: Perceived Risk Questionnaire: (includes 6 questions related to physical activity and regular consumption of fruits and vegetables) - Self-efficacy scale: (includes 6 questions related to self-efficacy and with a 5-point Likert scale E) - Awareness scale: (yes-no answer options) - Outcome expectation scale: (the scale consists of 5 questions and with 5-point answer options) - Action planning scale - Coping plan scale - Support scale social
2
Description
The main variable measured in this study is lifestyle items.
Timepoint
Before training-After training
Method of measurement
HAPA Questionnaire
3
Description
The main variable measured in this study is lifestyle items.
Timepoint
Before training-After training
Method of measurement
Nutrition Questionnaire -
Secondary outcomes
1
Description
Average perceived risk--
Timepoint
people are divided into two categories of control and intervention and are compared with each other.
Method of measurement
Knowledge-Nutrition-HAPA Questionnaire
2
Description
Average awareness-Self
Timepoint
people are divided into two categories of control and intervention and are compared with each other.
Method of measurement
Knowledge-Nutrition-HAPA Questionnaire
3
Description
efficacy-Expectation of outcome
Timepoint
people are divided into two categories of control and intervention and are compared with each other.
Method of measurement
Knowledge-Nutrition-HAPA Questionnaire
4
Description
Social support
Timepoint
people are divided into two categories of control and intervention and are compared with each other.
Method of measurement
Knowledge-Nutrition-HAPA Questionnaire
Intervention groups
1
Description
Intervention group: During 8 weeks, the intervention group receives training on the correct methods of food intake in people with diabetes, the effect of physical activity in controlling diabetes, and the consumption of fruits and vegetables in people with diabetes, and after 3 months of The last retraining session of the questionnaire is given to two experimental and control groups to answer the questions.
Category
Lifestyle
2
Description
In the control group, at first, the questionnaire is completed by elderly people with type 2 diabetes. And after 3 months, when the relevant training were passed to the intervention group, the questionnaires will be completed again in the two groups to measure the result and impact of the training in the two groups. Finally, training and explanations about lifestyle, physical activity and food in people with diabetes are also given to the control group so that they do not benefit from the study.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers
Full name of responsible person
Alireza Mehralian
Street address
Shahid Babayi St
City
qazvin
Province
Qazvin
Postal code
63111-34147
Phone
+98 28 3365 2972
Fax
+98 28 3365 8060
Email
infobhc@qums.ac.ir
Web page address
http://shbhc.qums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Peyman Namdar
Street address
Shahid Bahonar
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir/portal/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Isa Mohammadi Zeidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
imohammadi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Zanjanchi Nikoo
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Hakim Blvd
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
f.zanjanchinikoo@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme zanjanchi Nikoo
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Hakim Blvd
City
قزوین
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
f.zanjanchinikoo@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the data related to the main outcome can be shared
When the data will become available and for how long
Access starts 6 months after the results are published.
To whom data/document is available
Data is confidential.
Under which criteria data/document could be used
The data are examined for analysis.
From where data/document is obtainable
Fateme Zanjanchi Nikoo
What processes are involved for a request to access data/document